Role of Vitamin D in Treatment of Lumbar Disc Herniation: Pain and Sensory Aspects

Phase 2

Conditions: Condition 1: Lumbar Disc Herniation. Condition 2: Lumbar Disc Herniation.
Other specified intervertebral disc displacement
Lumbar and other intervertebral disc disorders with radiculopathy

Registration Number: IRCT2014050317534N1

Lead Sponsor: Vice Chancellor for Research Shiraz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 380

Inclusion Criteria

Inclusion Criteria:
1) No coexistent or preexisting spine pathology (e.g. Spondylolisis, Spondylolisthesis, Infection, Tumors, Fracture);
2) Single level lumbar disc herniation;
3) Discogenic pain duration from onset up physician evaluation: less than 8 weeks;
4) Compliance with study protocol;
5) Normal Lab studies;

Exclusion Criteria

1) Daily supplementation intake of more than 800 IU of vitamin D;
2) Serum calcium level more than 10.5 md/dl;
3) Hypercalciuria ( spot urine calcium creatinin ratio more than 0.4);
4) Lymphoma, Sarcoidosis, TB, Hyperparathyroidism, Celiac disease, malabsorption syndromes;
5) Hx of renal stone;
6) Hx of inflammatory back pain;
7) Impaired renal function tests (GFR less than 30);
8) Impaired hepatic function tests;
9) Abnormal Serum Phosphorus, Alkaline phosphatase and Parathyroid hormone values;
10) FBS more than 126;
11) Previous spine surgery;
12) Hx of trauma;
13) Taking Anticonvulsant, Anti-TB medications or vitamin D analogs;
14) Cauda Equina syndrome that requires emergency surgical decompression.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain. Timepoint: One initial and one final assessment will be performed at clinic.during 15-day conduction period, individuals will be contacted by phone every 3 days to comlete the questionnaires. Method of measurement: Visual analoque score for low back pain and radicular pain severity.

Secondary Outcome Measures

Name	Time	Method
Sensory deficits. Timepoint: One initial and one final assessment will be carried out at clinic.During 15-day conduction period, individuals will be contacted by phone every 3 days to comlete the questionnaires. Method of measurement: Mc-Gill questionnaire.